CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
GM-K562 cell vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00363649
NCT00363649Phase 2Completed

A Randomized Phase II Trial of Interferon + GM-CSF Versus K562/GM-CSF Vaccination in CML Patients Achieving a Complete Cytogenetic Response to Frontline Tyrosine Kinase Inhibitor Therapy

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 15, 2006·Updated Nov 13, 2018

In Brief

A Phase 2 clinical trial evaluating GM-K562 cell vaccine, Interferon alfa, and 1 other intervention for Leukemia. Completed, enrolled 36 participants across 1 site.

Detailed Summary

RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2006
Enrollment StartSep 1, 2006
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11 yearsPosted 19.9 years ago

Interventions

GM-K562 cell vaccinebiological

Given by injection

Interferon alfabiological

Given by injection

Sargramostimbiological

Given by injection